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3. An Open-Label Trial of Escitalopram in Pervasive Developmental Disorders.

Author

Owley, Thomas, Walton, Laura, Salt, Jeff, Guter, Stephen J., Winnega, Marrea, Leventhal, Bennett L., and Cook, Edwin H.

Abstract

Objective: To assess the effect of escitalopram in the treatment of pervasive developmental disorders (PDDs). Method: This 10-week study had a forced titration, open-label design. Twenty-eight subjects (mean age 125.1 [+ or -] 33.5 months) with a PDD received escitalopram at a dose that increased weekly to a maximum dose of 20 mg as tolerated. The Aberrant Behavior Checklist-Community Version (ABC-CV) and the Clinical Global Impression scale (CGI) were used to assess outcome. Results: There was significant improvement in ABC-CV Irritability Subscale Scores (baseline mean 20.5 [+ or -] 5.9 to final mean 10.9 [+ or -] 7.2; p [less than or equal to] .001) and in the other ABC-CV Subscales. Improvement on Clinical Global Improvement Scale severity rating was also significant (baseline mean 5.2 [+ or -] 1.0 to final mean 4.6 [+ or -] 1.2; p [less than or equal to] .001). Twenty-five percent of the subjects responded at a dose less than 10 mg and did not tolerate the 10-mg dose, and an additional 36% responded at a dose greater than or equal to 10 mg. Final dose was unrelated to weight and only weakly correlated with age. Conclusions: This open-label study found escitalopram to be useful in treating some difficulties common in PDDs. A wide variability in dose was found that could not be accounted for by weight and only partially by age. The study provides information useful for the design of double-blind, placebo-controlled studies of escitalopram in PDDs. J. Am. Acad. Child Adolesc. Psychiatry, 2005;44(4):343-348. Key Words: autistic disorder, escitalopram, drug treatment, open label.

Published
2005

4. The Scottish Centre for Autism Preschool Treatment Programme: II. The Results of a Controlled Treatment Outcome Study.

Author

Salt, Jeff, Shemilt, John, Sellars, Val, Boyd, Sheila, Coulson, Tracey, and McCool, Susan

Abstract

Evaluation of a developmentally based early intervention program for young children with autism in Scotland by comparison of treatment (n=14) and no-treatment (n=6) groups found treatment children improved significantly more than control group children on measures of joint attention, social interaction, imitation, daily living skills, motor skills, and an adaptive behavior composite. Results support the program's efficacy. (Contains references.) (Author/DB)

Published
2002

5. The Scottish Centre for Autism Preschool Treatment Programme. I: A Developmental Approach to Early Intervention.

Author

Salt, Jeff, Sellars, Val, Shemilt, John, Boyd, Sheila, Coulson, Tracey, and McCool, Susan

Abstract

This article describes the early intervention program developed at the Scottish Centre for Autism. Intervention aimed at improved social communication and social interaction skills is delivered through 1:1 intensive treatment by trained therapists and parent training. Treatment incorporates a child led approach, use of imitation, language use contingent on activities, and development of flexibility in play and social exchanges. (Contains references.) (Author/DB)

Published
2001

6. A genome-wide scan for common alleles affecting risk for autism

Author

Anney, Richard, Klei, Lambertus, Pinto, Dalila, Regan, Regina, Conroy, Judith, Magalhaes, Tiago R., Correia, Catarina, Abrahams, Brett S., Sykes, Nuala, Pagnamenta, Alistair T., Almeida, Joana, Bacchelli, Elena, Bailey, Anthony J., Baird, Gillian, Battaglia, Agatino, Berney, Tom, Bolshakova, Nadia, Bölte, Sven, Bolton, Patrick F., Bourgeron, Thomas, Brennan, Sean, Brian, Jessica, Carson, Andrew R., Casallo, Guillermo, Casey, Jillian, Chu, Su H., Cochrane, Lynne, Corsello, Christina, Crawford, Emily L., Crossett, Andrew, Dawson, Geraldine, de Jonge, Maretha, Delorme, Richard, Drmic, Irene, Duketis, Eftichia, Duque, Frederico, Estes, Annette, Farrar, Penny, Fernandez, Bridget A., Folstein, Susan E., Fombonne, Eric, Freitag, Christine M., Gilbert, John, Gillberg, Christopher, Glessner, Joseph T., Goldberg, Jeremy, Green, Jonathan, Guter, Stephen J., Hakonarson, Hakon, Heron, Elizabeth A., Hill, Matthew, Holt, Richard, Howe, Jennifer L., Hughes, Gillian, Hus, Vanessa, Igliozzi, Roberta, Kim, Cecilia, Klauck, Sabine M., Kolevzon, Alexander, Korvatska, Olena, Kustanovich, Vlad, Lajonchere, Clara M., Lamb, Janine A., Laskawiec, Magdalena, Leboyer, Marion, Le Couteur, Ann, Leventhal, Bennett L., Lionel, Anath C., Liu, Xiao-Qing, Lord, Catherine, Lotspeich, Linda, Lund, Sabata C., Maestrini, Elena, Mahoney, William, Mantoulan, Carine, Marshall, Christian R., McConachie, Helen, McDougle, Christopher J., McGrath, Jane, McMahon, William M., Melhem, Nadine M., Merikangas, Alison, Migita, Ohsuke, Minshew, Nancy J., Mirza, Ghazala K., Munson, Jeff, Nelson, Stanley F., Noakes, Carolyn, Noor, Abdul, Nygren, Gudrun, Oliveira, Guiomar, Papanikolaou, Katerina, Parr, Jeremy R., Parrini, Barbara, Paton, Tara, Pickles, Andrew, Piven, Joseph, Posey, David J, Poustka, Annemarie, Poustka, Fritz, Prasad, Aparna, Ragoussis, Jiannis, Renshaw, Katy, Rickaby, Jessica, Roberts, Wendy, Roeder, Kathryn, Roge, Bernadette, Rutter, Michael L., Bierut, Laura J., Rice, John P., Salt, Jeff, Sansom, Katherine, Sato, Daisuke, Segurado, Ricardo, Senman, Lili, Shah, Naisha, Sheffield, Val C., Soorya, Latha, Sousa, Inês, Stoppioni, Vera, Strawbridge, Christina, Tancredi, Raffaella, Tansey, Katherine, Thiruvahindrapduram, Bhooma, Thompson, Ann P., Thomson, Susanne, Tryfon, Ana, Tsiantis, John, Van Engeland, Herman, Vincent, John B., Volkmar, Fred, Wallace, Simon, Wang, Kai, Wang, Zhouzhi, Wassink, Thomas H., Wing, Kirsty, Wittemeyer, Kerstin, Wood, Shawn, Yaspan, Brian L., Zurawiecki, Danielle, Zwaigenbaum, Lonnie, Betancur, Catalina, Buxbaum, Joseph D., Cantor, Rita M., Cook, Edwin H., Coon, Hilary, Cuccaro, Michael L., Gallagher, Louise, Geschwind, Daniel H., Gill, Michael, Haines, Jonathan L., Miller, Judith, Monaco, Anthony P., Nurnberger, John I., Jr., Paterson, Andrew D., Pericak-Vance, Margaret A., Schellenberg, Gerard D., Scherer, Stephen W., Sutcliffe, James S., Szatmari, Peter, Vicente, Astrid M., Vieland, Veronica J., Wijsman, Ellen M., Devlin, Bernie, Ennis, Sean, and Hallmayer, Joachim

Published
2010
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7. Functional impact of global rare copy number variation in autism spectrum disorders

Author

Pinto, Dalila, Pagnamenta, Alistair T., Klei, Lambertus, Anney, Richard, Merico, Daniele, Regan, Regina, Conroy, Judith, Magalhaes, Tiago R., Correia, Catarina, Abrahams, Brett S., Almeida, Joana, Bacchelli, Elena, Bader, Gary D., Bailey, Anthony J., Baird, Gillian, Battaglia, Agatino, Berney, Tom, Bolshakova, Nadia, Bölte, Sven, Bolton, Patrick F., Bourgeron, Thomas, Brennan, Sean, Brian, Jessica, Bryson, Susan E., Carson, Andrew R., Casallo, Guillermo, Casey, Jillian, Chung, Brian H.Y., Cochrane, Lynne, Corsello, Christina, Crawford, Emily L., Crossett, Andrew, Cytrynbaum, Cheryl, Dawson, Geraldine, de Jonge, Maretha, Delorme, Richard, Drmic, Irene, Duketis, Eftichia, Duque, Frederico, Estes, Annette, Farrar, Penny, Fernandez, Bridget A., Folstein, Susan E., Fombonne, Eric, Freitag, Christine M., Gilbert, John, Gillberg, Christopher, Glessner, Joseph T., Goldberg, Jeremy, Green, Andrew, Green, Jonathan, Guter, Stephen J., Hakonarson, Hakon, Heron, Elizabeth A., Hill, Matthew, Holt, Richard, Howe, Jennifer L., Hughes, Gillian, Hus, Vanessa, Igliozzi, Roberta, Kim, Cecilia, Klauck, Sabine M., Kolevzon, Alexander, Korvatska, Olena, Kustanovich, Vlad, Lajonchere, Clara M., Lamb, Janine A., Laskawiec, Magdalena, Leboyer, Marion, Le Couteur, Ann, Leventhal, Bennett L., Lionel, Anath C., Liu, Xiao-Qing, Lord, Catherine, Lotspeich, Linda, Lund, Sabata C., Maestrini, Elena, Mahoney, William, Mantoulan, Carine, Marshall, Christian R., McConachie, Helen, McDougle, Christopher J., McGrath, Jane, McMahon, William M., Merikangas, Alison, Migita, Ohsuke, Minshew, Nancy J., Mirza, Ghazala K., Munson, Jeff, Nelson, Stanley F., Noakes, Carolyn, Noor, Abdul, Nygren, Gudrun, Oliveira, Guiomar, Papanikolaou, Katerina, Parr, Jeremy R., Parrini, Barbara, Paton, Tara, Pickles, Andrew, Pilorge, Marion, Piven, Joseph, Ponting, Chris P., Posey, David J., Poustka, Annemarie, Poustka, Fritz, Prasad, Aparna, Ragoussis, Jiannis, Renshaw, Katy, Rickaby, Jessica, Roberts, Wendy, Roeder, Kathryn, Roge, Bernadette, Rutter, Michael L., Bierut, Laura J., Rice, John P., Salt, Jeff, Sansom, Katherine, Sato, Daisuke, Segurado, Ricardo, Sequeira, Ana F., Senman, Lili, Shah, Naisha, Sheffield, Val C., Soorya, Latha, Sousa, Inês, Stein, Olaf, Sykes, Nuala, Stoppioni, Vera, Strawbridge, Christina, Tancredi, Raffaella, Tansey, Katherine, Thiruvahindrapduram, Bhooma, Thompson, Ann P., Thomson, Susanne, Tryfon, Ana, Tsiantis, John, Van Engeland, Herman, Vincent, John B., Volkmar, Fred, Wallace, Simon, Wang, Kai, Wang, Zhouzhi, Wassink, Thomas H., Webber, Caleb, Weksberg, Rosanna, Wing, Kirsty, Wittemeyer, Kerstin, Wood, Shawn, Wu, Jing, Yaspan, Brian L., Zurawiecki, Danielle, Zwaigenbaum, Lonnie, Buxbaum, Joseph D., Cantor, Rita M., Cook, Edwin H., Coon, Hilary, Cuccaro, Michael L., Devlin, Bernie, Ennis, Sean, Gallagher, Louise, Geschwind, Daniel H., Gill, Michael, Haines, Jonathan L., Hallmayer, Joachim, Miller, Judith, Monaco, Anthony P., Nurnberger, John I., Jr, Paterson, Andrew D., Pericak-Vance, Margaret A., Schellenberg, Gerard D., Szatmari, Peter, Vicente, Astrid M., Vieland, Veronica J., Wijsman, Ellen M., Scherer, Stephen W., Sutcliffe, James S., and Betancur, Catalina

Published
2010
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8. A genome-wide linkage and association scan reveals novel loci for autism

Author

Weiss, Lauren A., Arking, Dan E., Daly, Mark J., Chakravarti, Aravinda, Brune, Camille W., West, Kristen, O’Connor, Ashley, Hilton, Gina, Tomlinson, Rebecca L., West, Andrew B., Cook, Edwin H., Jr, Green, Todd, Chang, Shun-Chiao, Gabriel, Stacey, Gates, Casey, Hanson, Ellen M., Kirby, Andrew, Korn, Joshua, Kuruvilla, Finny, McCarroll, Steven, Morrow, Eric M., Neale, Benjamin, Purcell, Shaun, Sasanfar, Roksana, Sougnez, Carrie, Stevens, Christine, Altshuler, David, Gusella, James, Santangelo, Susan L., Sklar, Pamela, Tanzi, Rudolph, Anney, Richard, Bailey, Anthony J., Baird, Gillian, Battaglia, Agatino, Berney, Tom, Betancur, Catalina, Bölte, Sven, Bolton, Patrick F., Brian, Jessica, Bryson, Susan E., Buxbaum, Joseph D., Cabrito, Ines, Cai, Guiqing, Cantor, Rita M., Coon, Hilary, Conroy, Judith, Correia, Catarina, Corsello, Christina, Crawford, Emily L., Cuccaro, Michael L., Dawson, Geraldine, de Jonge, Maretha, Devlin, Bernie, Duketis, Eftichia, Ennis, Sean, Estes, Annette, Farrar, Penny, Fombonne, Eric, Freitag, Christine M., Gallagher, Louise, Geschwind, Daniel H., Gilbert, John, Gill, Michael, Gillberg, Christopher, Goldberg, Jeremy, Green, Andrew, Green, Jonathan, Guter, Stephen J., Haines, Jonathan L., Hallmayer, Joachim F., Hus, Vanessa, Klauck, Sabine M., Korvatska, Olena, Lamb, Janine A., Laskawiec, Magdalena, Leboyer, Marion, Le Couteur, Ann, Leventhal, Bennett L., Liu, Xiao-Qing, Lord, Catherine, Lotspeich, Linda J., Maestrini, Elena, Magalhaes, Tiago, Mahoney, William, Mantoulan, Carine, McConachie, Helen, McDougle, Christopher J., McMahon, William M., Marshall, Christian R., Miller, Judith, Minshew, Nancy J., Monaco, Anthony P., Munson, Jeff, Nurnberger, John I., Jr, Oliveira, Guiomar, Pagnamenta, Alistair, Papanikolaou, Katerina, Parr, Jeremy R., Paterson, Andrew D., Pericak-Vance, Margaret A., Pickles, Andrew, Pinto, Dalila, Piven, Joseph, Posey, David J., Poustka, Annemarie, Poustka, Fritz, Regan, Regina, Reichert, Jennifer, Renshaw, Katy, Roberts, Wendy, Roge, Bernadette, Rutter, Michael L., Salt, Jeff, Schellenberg, Gerard D., Scherer, Stephen W., Sheffield, Val, Sutcliffe, James S., Szatmari, Peter, Tansey, Katherine, Thompson, Ann P., Tsiantis, John, Van Engeland, Herman, Vicente, Astrid M., Vieland, Veronica J., Volkmar, Fred, Wallace, Simon, Wassink, Thomas H., Wijsman, Ellen M., Wing, Kirsty, Wittemeyer, Kerstin, Yaspan, Brian L., Zwaigenbaum, Lonnie, Yoo, Seung-Yun, Sean Hill, Robert, Mukaddes, Nahit M., Balkhy, Soher, Gascon, Generoso, Al-Saad, Samira, Hashmi, Asif, Ware, Janice, Joseph, Robert M., LeClair, Elaine, Partlow, Jennifer N., Barry, Brenda, Walsh, Christopher A., Pauls, David, Moilanen, Irma, Ebeling, Hanna, Mattila, Marja-Leena, Kuusikko, Sanna, Jussila, Katja, Ignatius, Jaakko, Tolouei, Ala, Ghadami, Majid, Rostami, Maryam, Hosseinipour, Azam, Valujerdi, Maryam, Andresen, Kara, Winkloski, Brian, Haddad, Stephen, Kunkel, Lou, Kohane, Zak, Tran, Tram, Won Kong, Sek, O’Neil, Stephanie Brewster, Hundley, Rachel, Holm, Ingrid, Peters, Heather, Baroni, Elizabeth, Cangialose, Aislyn, Jackson, Lindsay, Albers, Lisa, Becker, Ronald, Bridgemohan, Carolyn, Friedman, Sandra, Munir, Kerim, Nazir, Ramzi, Palfrey, Judith, Schonwald, Alison, Simmons, Esau, Rappaport, Leonard A., Gauthier, Julie, Mottron, Laurent, Joober, Ridha, Rouleau, Guy, Rehnstrom, Karola, von Wendt, Lennart, and Peltonen, Leena

Published
2009
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12. Effect of CX516, an AMPA-Modulating Compound, on Cognition and Behavior in Fragile X Syndrome: AControlled Trial

Author

Berry-Kravis, Elizabeth, primary, Krause, Sue Ellen, additional, Block, Sandra S., additional, Guter, Steve, additional, Wuu, Joanne, additional, Leurgans, Sue, additional, Decle, Penelope, additional, Potanos, Kristina, additional, Cook, Edwin, additional, Salt, Jeff, additional, Maino, Dominick, additional, Weinberg, Dahlia, additional, Lara, Rebecca, additional, Jardini, Tristan, additional, Cogswell, Jennifer, additional, Johnson, Steven A., additional, and Hagerman, Randi, additional

Published
2006
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15. A pharmacogenetic study of escitalopram in autism spectrum disorders.

Author

Owley, Thomas, Brune, Camille W., Salt, Jeff, Walton, Laura, Guter, Steve, Ayuyao, Nelson, Gibbons, Robert D., Leventhal, Bennett L., and Cook, Edwin H.

Abstract

Objective: To determine the effect of serotonin transporter polymorphism promoter region (5-HTTPLR) genotypic variation (low, intermediate, and high expression groups) on response to escitalopram treatment of children and adolescents with autism spectrum disorders (ASDs). Method: The study used a forced titration, open label design, with genotype blind until study completion. Participants were children and adolescents aged 4-17 years of age with a confirmed ASD (autistic disorder, Asperger's disorder, or pervasive developmental disorder, not otherwise specified). Results: There was an interaction between genotype group and time on the Aberrant Behavior Checklist (ABC) Irritability Subscale (primary outcome variable) (linear maximum marginal likelihood estimation=-4.84, Z=-2.89, SE=1.67, P=0.004). Examination of baseline to last visit revealed that a genotype grouping based on a previous study of platelet 5-HT uptake revealed less response in the genotype group that had S/S genotype for 5-HTTLPR and did not have a diplotype in intron 1 previously shown to be associated with increased platelet 5-HT uptake. Conclusion: This genotype-blind, prospective pharmacogenetic study found the group of subjects with associated with the lowest platelet 5-HT uptake from previous study had the smallest reduction in ABC-Irritability scores after open label treatment with escitalopram. Replication is necessary to confirm these findings. [ABSTRACT FROM AUTHOR]

Published
2010
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18. A pharmacogenetic study of escitalopram in autism spectrum disorders.

Author

Owley T, Brune CW, Salt J, Walton L, Guter S, Ayuyao N, Gibbons RD, Leventhal BL, and Cook EH

Subjects
Adolescent, Blood Platelets metabolism, Child, Child Development Disorders, Pervasive psychology, Child, Preschool, Dose-Response Relationship, Drug, Female, Humans, Introns genetics, Irritable Mood drug effects, Male, Personality Assessment, Pharmacogenetics, Serotonin blood, Treatment Outcome, Antidepressive Agents, Second-Generation therapeutic use, Child Development Disorders, Pervasive drug therapy, Child Development Disorders, Pervasive genetics, Citalopram therapeutic use, Genotype, Serotonin Plasma Membrane Transport Proteins genetics, Selective Serotonin Reuptake Inhibitors therapeutic use
Abstract

Objective: To determine the effect of serotonin transporter polymorphism promoter region (5-HTTPLR) genotypic variation (low, intermediate, and high expression groups) on response to escitalopram treatment of children and adolescents with autism spectrum disorders (ASDs)., Method: The study used a forced titration, open label design, with genotype blind until study completion. Participants were children and adolescents aged 4-17 years of age with a confirmed ASD (autistic disorder, Asperger's disorder, or pervasive developmental disorder, not otherwise specified)., Results: There was an interaction between genotype group and time on the Aberrant Behavior Checklist (ABC) Irritability Subscale (primary outcome variable) (linear maximum marginal likelihood estimation=-4.84, Z=-2.89, SE=1.67, P=0.004). Examination of baseline to last visit revealed that a genotype grouping based on a previous study of platelet 5-HT uptake revealed less response in the genotype group that had S/S genotype for 5-HTTLPR and did not have a diplotype in intron 1 previously shown to be associated with increased platelet 5-HT uptake., Conclusion: This genotype-blind, prospective pharmacogenetic study found the group of subjects with associated with the lowest platelet 5-HT uptake from previous study had the smallest reduction in ABC-Irritability scores after open label treatment with escitalopram. Replication is necessary to confirm these findings.

Published
2010
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19. Mapping autism risk loci using genetic linkage and chromosomal rearrangements.

Author

Szatmari P, Paterson AD, Zwaigenbaum L, Roberts W, Brian J, Liu XQ, Vincent JB, Skaug JL, Thompson AP, Senman L, Feuk L, Qian C, Bryson SE, Jones MB, Marshall CR, Scherer SW, Vieland VJ, Bartlett C, Mangin LV, Goedken R, Segre A, Pericak-Vance MA, Cuccaro ML, Gilbert JR, Wright HH, Abramson RK, Betancur C, Bourgeron T, Gillberg C, Leboyer M, Buxbaum JD, Davis KL, Hollander E, Silverman JM, Hallmayer J, Lotspeich L, Sutcliffe JS, Haines JL, Folstein SE, Piven J, Wassink TH, Sheffield V, Geschwind DH, Bucan M, Brown WT, Cantor RM, Constantino JN, Gilliam TC, Herbert M, Lajonchere C, Ledbetter DH, Lese-Martin C, Miller J, Nelson S, Samango-Sprouse CA, Spence S, State M, Tanzi RE, Coon H, Dawson G, Devlin B, Estes A, Flodman P, Klei L, McMahon WM, Minshew N, Munson J, Korvatska E, Rodier PM, Schellenberg GD, Smith M, Spence MA, Stodgell C, Tepper PG, Wijsman EM, Yu CE, Rogé B, Mantoulan C, Wittemeyer K, Poustka A, Felder B, Klauck SM, Schuster C, Poustka F, Bölte S, Feineis-Matthews S, Herbrecht E, Schmötzer G, Tsiantis J, Papanikolaou K, Maestrini E, Bacchelli E, Blasi F, Carone S, Toma C, Van Engeland H, de Jonge M, Kemner C, Koop F, Langemeijer M, Hijmans C, Staal WG, Baird G, Bolton PF, Rutter ML, Weisblatt E, Green J, Aldred C, Wilkinson JA, Pickles A, Le Couteur A, Berney T, McConachie H, Bailey AJ, Francis K, Honeyman G, Hutchinson A, Parr JR, Wallace S, Monaco AP, Barnby G, Kobayashi K, Lamb JA, Sousa I, Sykes N, Cook EH, Guter SJ, Leventhal BL, Salt J, Lord C, Corsello C, Hus V, Weeks DE, Volkmar F, Tauber M, Fombonne E, Shih A, and Meyer KJ

Subjects
Autistic Disorder diagnosis, Family, Female, Genetic Variation, Humans, Lod Score, Male, Risk Factors, Autistic Disorder genetics, Chromosome Aberrations, Chromosome Mapping, Genetic Linkage, Genetic Predisposition to Disease, Genetic Testing methods
Abstract

Autism spectrum disorders (ASDs) are common, heritable neurodevelopmental conditions. The genetic architecture of ASDs is complex, requiring large samples to overcome heterogeneity. Here we broaden coverage and sample size relative to other studies of ASDs by using Affymetrix 10K SNP arrays and 1,181 [corrected] families with at least two affected individuals, performing the largest linkage scan to date while also analyzing copy number variation in these families. Linkage and copy number variation analyses implicate chromosome 11p12-p13 and neurexins, respectively, among other candidate loci. Neurexins team with previously implicated neuroligins for glutamatergic synaptogenesis, highlighting glutamate-related genes as promising candidates for contributing to ASDs.

Published
2007
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20. A prospective, open-label trial of memantine in the treatment of cognitive, behavioral, and memory dysfunction in pervasive developmental disorders.

Author

Owley T, Salt J, Guter S, Grieve A, Walton L, Ayuyao N, Leventhal BL, and Cook EH Jr

Subjects
Child, Child Behavior Disorders diagnosis, Child Behavior Disorders psychology, Child Development Disorders, Pervasive diagnosis, Child Development Disorders, Pervasive psychology, Child, Preschool, Cognition Disorders diagnosis, Cognition Disorders psychology, Dose-Response Relationship, Drug, Female, Glutamic Acid metabolism, Humans, Intelligence drug effects, Language Development Disorders diagnosis, Language Development Disorders drug therapy, Language Development Disorders psychology, Male, Memory Disorders diagnosis, Memory Disorders psychology, Neuropsychological Tests, Prospective Studies, Treatment Outcome, Child Behavior Disorders drug therapy, Child Development Disorders, Pervasive drug therapy, Cognition Disorders drug therapy, Excitatory Amino Acid Antagonists therapeutic use, Memantine therapeutic use, Memory Disorders drug therapy
Abstract

Background: This pilot study examined the effectiveness of memantine hydrochloride in improving cognitive functioning and behavioral symptoms in children with pervasive developmental disorders (PDDs)., Method: Subjects aged 3-12 years inclusive were enrolled in this 8-week, open-label study. Expressive and receptive language, nonverbal IQ, and nonverbal memory measures were administered at baseline and after 8 weeks of treatment with 0.4 mg/kg of memantine hydrochloride. Throughout the study, the Aberrant Behavior Checklist (ABC) was sent in weekly by parents as a measure of behavioral change., Results: Twelve of 14 subjects completed the study. Significant improvement from baseline was noted on the memory test (Children's Memory Scale Dot Learning Subtest). There were no significant differences from baseline on measures of expressive or receptive language or nonverbal IQ. There were significant improvements on a number of ABC subscales, including hyperactivity, lethargy, and irritability. There were no overall significant statistical differences from baseline on the Clinical Global Improvement-Severity (CGI-S) scale. On the Clinical Global Improvement-Improvement (CGI-I), 4 of 14 subjects showed minimal improvement, and none was deemed "much-improved" or "very much improved.", Conclusions: This small, prospective, open-label study suggests that memantine may be useful in the treatment of memory functioning and some behavioral symptoms in PDDs. The investigators did not see the same degree of change as endorsed by caretakers. Controlled studies are needed to substantiate and clarify these preliminary findings.

Published
2006
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21. Effect of CX516, an AMPA-modulating compound, on cognition and behavior in fragile X syndrome: a controlled trial.

Author

Berry-Kravis E, Krause SE, Block SS, Guter S, Wuu J, Leurgans S, Decle P, Potanos K, Cook E, Salt J, Maino D, Weinberg D, Lara R, Jardini T, Cogswell J, Johnson SA, and Hagerman R

Subjects
Adolescent, Adult, Autistic Disorder drug therapy, Autistic Disorder psychology, Child Behavior Disorders psychology, Cognition Disorders psychology, Dioxoles adverse effects, Dose-Response Relationship, Drug, Double-Blind Method, Drug Eruptions etiology, Female, Fragile X Syndrome psychology, Humans, Long-Term Potentiation drug effects, Male, Neuronal Plasticity drug effects, Neuropsychological Tests, Personality Assessment, Piperidines adverse effects, Synaptic Transmission drug effects, Treatment Outcome, Child Behavior Disorders drug therapy, Cognition Disorders drug therapy, Dioxoles therapeutic use, Fragile X Syndrome drug therapy, Piperidines therapeutic use, Receptors, AMPA drug effects
Abstract

A Phase II, 4-week randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the safety and efficacy of the Ampakine compound CX516 as a potential treatment for the underlying disorder in fragile X syndrome (FXS). After baseline screening, subjects with FXS (n = 49) underwent a 1-week placebo lead-in and then were randomized to study drug or placebo for a 4-week period. Cognitive and behavioral outcome measures were administered prior to treatment, at the end of treatment, and 2 weeks posttreatment. There were minimal side effects, no significant changes in safety parameters, and no serious adverse events. There was a 12.5% frequency of allergic rash in the CX516 group and 1 subject developed a substantial rash. There was also no significant improvement in memory, the primary outcome measure, or in secondary measures of language, attention/executive function, behavior, and overall functioning in CX516-treated subjects compared to placebo. This study did demonstrate that many outcome measures were reproducible in this test-retest setting for the FXS population, yet some were too difficult or variable. Adult subjects with FXS were able to complete an intensive clinical trial, and some valid outcome measures were identified for future FXS trial design. Problems with potency of CX516 in other studies have suggested dosing may have been inadequate for therapeutic effect and thus it remains unclear whether modulation of AMPA-mediated neurotransmission is a viable therapeutic strategy for the treatment of FXS.

Published
2006
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